P2B-033

State Health Centre Oncology Department (Budapest, Hungary) › P2B-033

P2B-033

A Multicenter, Randomized, Open-Label Phase 2b Study to Investigate the Preliminary Efficacy and Safety of INNO-206 (Doxorubicin-EMCH) Compared to Doxorubicin in Subjects With Metastatic, Locally Advanced, or Unresectable Soft Tissue Sarcoma · Phase II
State Health Centre Oncology Department (Budapest, Hungary) · Dr. Clarke
consented 2012-09-09

completed

AEs

6

Serious

0

Dropout signal

–

Adverse events

6

Grade 2 anaemia with onset in cycle 3 (2012-11-24); assessed as related to study drug (probable); resolved 2012-12-07.

moderate assessed

Grade 4 febrile neutropenia with onset in cycle 2 (2012-11-05); assessed as related to study drug (probable); resolved 2012-11-10.

severe assessed

Grade 4 neutropenia with onset in cycle 2 (2012-11-04); assessed as related to study drug (probable); resolved 2012-11-13; action: drug interrupted.

severe assessed

Grade 1 diarrhoea with onset in cycle 1 (2012-10-02); assessed as not related to study drug (unlikely); resolved 2012-10-07.

mild assessed

Grade 1 constipation with onset in cycle 1 (2012-09-30); assessed as not related to study drug (not related); resolved 2012-10-04.

mild assessed

Grade 2 vomiting with onset in cycle 1 (2012-09-26); assessed as not related to study drug (unlikely); resolved 2012-09-28.

moderate assessed

Data queries

4

Visit Cycle 3 Day 1: infusion; week-6 CT/MRI and ECHO/MUGA before dosing (V4) for P2B-033 occurred on 2012-11-19, 12 d late against planned day 43 (2012-11-07 ± 3 d, anchored on first dose 2012-09-26). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V4] open

AE Febrile neutropenia (grade 4) for P2B-033 (onset 2012-11-05) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Febrile neutropenia 2012-11-05] open

AE Neutropenia (grade 4) for P2B-033 (onset 2012-11-04) is CTCAE grade 4 but not flagged serious. Confirm seriousness assessment — grade 4/5 events are life-threatening or fatal by definition.

serious[Neutropenia 2012-11-04] open

Visit Cycle 2 Day 1: infusion (V3) for P2B-033 occurred on 2012-10-29, 12 d late against planned day 22 (2012-10-17 ± 3 d, anchored on first dose 2012-09-26). Confirm the visit date or record a protocol deviation.

SV.occurred_on[V3] open